Control of circulatory assist systems

ABSTRACT

In one general aspect, a method includes measuring blood flow through a right rotary blood pump, measuring blood flow through a left rotary blood pump, and controlling a speed of one of the rotary blood pumps using a controller that calculates the speed of one of the rotary blood pumps based on the measured blood flow through the other rotary blood pump.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.13/242,248, filed Sep. 23, 2011, which application claims the benefit ofU.S. Provisional Application No. 61/386,018, filed Sep. 24, 2010 andclaims the benefit of U.S. Provisional Application No. 61/472,241, filedApr. 6, 2011, the entire contents of which are hereby incorporated byreference in their entirety for all purposes.

TECHNICAL FIELD

This disclosure relates to control of circulatory assist systems.

BACKGROUND

Heart assist devices or pumps can be inserted in the circulatory systemto pump blood from either ventricle or atrium of a heart to thevasculature. A pump supplementing a ventricle is known as a ventricularassist device, or VAD. A VAD is useful when the ventricle alone isincapable of providing adequate blood flow. A pump can also completelyreplace the function of a ventricle. It is known to use two blood pumps,one assisting or replacing the right ventricle and one assisting orreplacing the left ventricle.

BRIEF SUMMARY

In one general aspect, a blood pump controller can set the motor speedof a blood pump based on blood flow through another blood pump. Oneblood pump can support a left ventricle and the other blood pump cansupport a right ventricle.

In another general aspect, a blood pump controller for controlling rightand left rotary blood pumps includes an input interface configured toreceive a signal indicating blood flow through a right rotary blood pumpand a signal indicating blood flow through a left rotary blood pump. Theblood pump controller includes a processing unit configured to calculatea speed of one of the rotary blood pumps based on the blood flow throughthe other blood pump, and to control one of the rotary blood pumps tooperate at the calculated speed.

In another general aspect, a controller for a heart assist systemincludes a processing unit configured to generate a pulsatility indexfor a right blood pump, set a speed of the right blood pump based on thepulsatility index for the right blood pump, generate a pulsatility indexfor a left blood pump, and set a speed of the left blood pump based onthe pulsatility index for the left blood pump.

In another general aspect, a method of controlling blood flow includesmeasuring blood flow through a right rotary blood pump, measuring bloodflow through a left rotary blood pump, and controlling a speed of one ofthe rotary blood pumps using a controller that calculates the speed ofone of the rotary blood pumps based on the measured blood flow throughthe other rotary blood pump.

Implementations can include one or more of the following features. Forexample, the left blood pump supplies blood to a vasculature; the rightblood pump supplies blood to a pulmonary system; and controlling a speedof one of the blood pumps using a controller that calculates the speedof one of the blood pumps based on the measured blood flow of the otherblood pump includes controlling a speed of one of the blood pumps suchthat the blood flow through the right rotary blood pump is less than theblood flow through the left rotary blood pump. Controlling a speed ofone of the blood pumps such that the blood flow through the right rotaryblood pump is less than the blood flow through the left rotary bloodpump includes controlling a speed of one of the blood pumps such thatthe blood flow through the right rotary blood pump is less than theblood flow through the left rotary blood pump by a minimum percentage ofblood flow.

Implementations can also include one or more of the following features.For example, controlling a speed of one of the blood pumps using acontroller that calculates the speed of one of the blood pumps based onthe measured blood flow of the other blood pump includes determiningthat the measured blood flow through the right rotary blood pump haschanged or that the measured blood flow through the left rotary bloodpump has changed; and in response to determining that the measured bloodflow through the right rotary blood pump has changed or that themeasured blood flow through the left rotary blood pump has changed,adjusting the speed of the one of the blood pumps based on the measuredblood flow through the other blood pump.

Implementations can also include one or more of the following features.For example, controlling a speed of one of the rotary blood pumps usinga controller that calculates the speed of one of the rotary blood pumpsbased on the measured blood flow through the other rotary blood pumpincludes determining that a predetermined relationship between themeasured blood flow through the right rotary blood pump and the measuredblood flow through the left rotary blood pump is not satisfied; and inresponse to determining that the predetermined relationship is notsatisfied, adjusting the speed of one of the rotary blood pumps suchthat the predetermined relationship is achieved. Controlling a speed ofone of the rotary blood pumps using a controller that calculates thespeed of one of the rotary blood pumps based on the measured blood flowthrough the other rotary blood pump includes determining that themeasured blood flow through one of the rotary blood pumps exceeds athreshold; and reducing the speed of one of the blood pumps such thatthe measured blood flow is reduced below the threshold.

Implementations can also include one or more of the following features.For example, while controlling the speed of one of the rotary bloodpumps using the controller that calculates the speed of one of therotary blood pumps based on the measured blood flow through the otherrotary blood pump, the speed of the other rotary blood pump can becontrolled to generate a pulsatile flow. Operating a selected blood pumpof the rotary blood pumps at a first speed for a first period of time;reducing the speed of the selected blood pump from the first speed to asecond speed; operating the selected blood pump at the second speed fora second period of time; reducing the speed of the selected blood pumpfrom the second speed to a third speed; operating the selected bloodpump at the third speed for a third period of time; and increasing thespeed of the selected blood pump from the third speed to the firstspeed. Controlling one of the rotary blood pumps to generate a rate ofpressure change that simulates a natural physiologic pulse. Controllingone of the rotary blood pumps to generate a rate of pressure change thatsimulates a natural physiologic pulse includes changing the operatingspeed of one of the rotary blood pumps from a first speed to a secondspeed higher than the first speed such that the operating speedovershoots the second speed to produce the rate of pressure change thatsimulates a pressure change of a natural physiologic pulse.

In another general aspect, a method of controlling a heart assist systemincludes calculating a pulsatility index for a right blood pump, theright blood pump supporting a right ventricle, controlling the speed ofthe right blood pump based on the pulsatility index for the right bloodpump, calculating a pulsatility index for a left blood pump, the leftblood pump supporting a left ventricle, and controlling the speed of theleft blood pump based on the pulsatility index for the left blood pump.

Implementations can include one or more of the following features. Forexample, the right blood pump is a rotary pump, and the left blood pumpis a rotary pump. The pulsatility index for the right blood pumpindicates a load on the right ventricle experienced during contractionof the right ventricle, and the pulsatility index for the left bloodpump indicates a load on the left ventricle experienced duringcontraction of the left ventricle. Each pulsatility index (PI) iscalculated over a control interval according to the following equation:PI=(Q_(max)−Q_(min))/Q_(ave), where Q_(max) is a maximum flow ratethrough the pump in the control interval, Q_(min) is a minimum flow ratethrough the pump in the control interval, and Q_(ave) is an average flowrate through the pump over the control interval. Measuring blood flowthrough the right blood pump, measuring blood flow through the leftblood pump, and controlling a speed of one of the rotary blood pumpsbased on the measured blood flow through the other blood pump.

Implementations can also include one or more of the following features.For example, determining whether the blood flow through one of the bloodpumps exceeds a flow threshold, and controlling the speed of the rightblood pump and controlling the speed of the left blood pump include,when the pulsatility index for the right blood pump is below a firsttarget level and the pulsatility index for the left blood pump is belowa second target level: when the blood flow through the one of the bloodpumps does not exceed the flow threshold, decreasing the speed of theright blood pump and decreasing the speed of the left blood pump, andwhen the blood flow through the one of the blood pumps exceeds the flowthreshold, maintaining the speed of the right blood pump and maintainingthe speed of the left blood pump. Controlling a speed of one of therotary blood pumps based on the measured blood flow through the otherblood pump includes determining that a relationship between the measuredblood flow through the right blood pump and the measured blood flowthrough the left blood pump is not satisfied, and in response todetermining that the relationship is not satisfied, adjusting the speedof the one of the blood pumps such that the relationship is achieved.

Implementations can also include one or more of the following features.For example, controlling the speed of the right blood pump is furtherbased on the pulsatility index for the left blood pump. Controlling thespeed of the left blood pump is further based on the pulsatility indexfor the right blood pump. Detecting a heart rate, and controlling thespeed of the right blood pump is further based on the heart rate, andcontrolling the speed of the left blood pump is further based on theheart rate. Determining whether the heart rate exceeds a threshold heartrate, and controlling the speed of the right blood pump and controllingthe speed of the left blood pump include, when the pulsatility index forthe right blood pump is below a first target level and the pulsatilityindex for the left blood pump is below a second target level: when theheart rate does not exceed the threshold heart rate, decreasing thespeed of the right blood pump and decreasing the speed of the left bloodpump, and when the heart rate exceeds the threshold heart rate,maintaining the speed of the right blood pump and maintaining the speedof the left blood pump.

Implementations can also include one or more of the following features.For example, operating one of the blood pumps to produce an artificiallyinduced pulsatile blood flow and calculating the correspondingpulsatility index for the blood pump that produces the artificiallyinduced pulsatile flow such that data influenced by artificial bloodflow variations of the artificially induced pulsatile blood flow areexcluded from the calculating the corresponding pulsatility index.Operating the left blood pump to produce an artificially inducedpulsatile blood flow, and calculating the left pulsatility index suchthat data influenced by artificial blood flow variations of theartificially induced pulsatile blood flow are excluded from calculatingthe left pulsatility index.

Implementations can also include one or more of the following features.For example, after controlling the speed of the right blood pump basedon the pulsatility index for the right blood pump for a first period oftime, controlling the speed of the right blood pump to generate a rateof pressure change that simulates a natural physiologic pulse. Aftercontrolling the speed of the left blood pump based on the pulsatilityindex for the left blood pump, controlling the speed of the left bloodpump to generate a rate of pressure change that simulates a naturalphysiologic pulse. Alternating control of the left blood pump or theright blood pump between (i) control based on a pulsatility index and(ii) control to generate a rate of pressure change that simulates anatural physiologic pulse. Repeating a cycle that includes: controllinga selected blood pump of the blood pumps based on the correspondingpulsatility index for a first period of time; and controlling theselected blood pump to generate a pulsatile flow during a second periodof time. Controlling the selected blood pump to generate a pulsatileflow during a second period of time includes controlling the selectedblood pump to generate a rate of pressure change that simulates anatural physiologic pulse during the second period of time. Controllingthe selected blood pump to generate a rate of pressure change thatsimulates a natural physiologic pulse for a second period of timeincludes generating the rate of pressure change that simulates thenatural physiologic pulse by changing an operating speed of the selectedpump from a first speed to a second speed higher than the first speedsuch that the operating speed overshoots the second speed.

Implementations can also include one or more of the following features.For example, controlling the selected pump to generate a pulsatile flowduring a second period of time includes: operating a selected blood pumpof the rotary blood pumps at a first speed for a first period of time;reducing the speed of the selected blood pump from the first speed to asecond speed; operating the selected blood pump at the second speed fora second period of time; reducing the speed of the selected blood pumpfrom the second speed to a third speed; operating the selected bloodpump at the third speed for a third period of time; and increasing thespeed of the selected blood pump from the third speed to the firstspeed. Operating a selected pump of the blood pumps to generate apulsatile flow, including: operating the selected blood pump to producea first blood flow rate through the selected blood pump associated withthe relatively low pressure portion of the pulsatile blood flow,operating the selected blood pump to produce a second blood flow ratethrough the selected blood pump associated with the relatively highpressure portion of the pulsatile blood flow, and controlling theselected blood pump to increase a blood flow rate through the selectedblood pump from the first flow rate to the second flow rate to producethe rate of pressure change that mimics the rate of pressure change ofthe natural physiologic pulse.

Implementations can also include one or more of the following features.For example, increasing the speed of the selected blood pump from thethird speed to the first speed includes increasing the speed of theselected blood pump from the third speed to a fourth speed, operatingthe selected blood pump at the fourth speed for a fourth period of time,and increasing the speed of the selected blood pump from the fourthspeed to the first speed. The second period of time is longer than a sumof the first period of time and the third period of time. Operating theselected blood pump at the first speed, reducing the speed of theselected blood pump from the first speed to the second speed, operatingthe selected blood pump at the second speed, reducing the speed of theselected blood pump from the second speed to the third speed, operatingthe selected blood pump at the third speed, and increasing the speed ofthe selected blood pump from the third speed to the first speed comprisea cycle, and pumping blood in a pulsatile manner further includesrepeating the cycle. The duration of the second period of time isgreater than half of the duration of the cycle. Operating the selectedblood pump at the second speed for the second period of time includesoperating the selected blood pump to produce a blood flow rate that hasa predetermined relationship relative to an average blood flow rate forthe cycle. Operating the selected blood pump at the second speed for thesecond period of time includes operating the selected blood pump toproduce a blood flow substantially the same as the average blood flowrate for the cycle.

Implementations can also include one or more of the following features.For example, one or more of reducing the speed of the selected bloodpump from the first speed to a second speed, reducing the speed of theselected blood pump from the second speed to a third speed, andincreasing the speed of the selected blood pump from the third speed tothe first speed includes one or more of a step-wise reduction in speedand a curvilinear reduction in speed. Operating the selected blood pumpat the second speed includes operating the selected blood pump at thesecond speed during at least a portion of a contraction of a ventricleof human heart that is in blood flow communication with the selectedblood pump. Pumping blood in a pulsatile manner also includesdetermining, based on a relationship between a speed of the selectedblood pump and a power consumption of the selected blood pump, asynchronization between operating the impeller at the second speed andcontraction of a ventricle of a human heart that is in blood flowcommunication with the selected blood pump. A generated pulsatile bloodflow includes a temporal rate of change of blood pressure thatapproximates a temporal rate of change of blood pressure of aphysiologic pulse. One or more of reducing the speed of the selectedblood pump from the first speed to a second speed, reducing the speed ofthe selected blood pump from the second speed to a third speed, andincreasing the speed of the selected blood pump from the third speed tothe first speed includes generating a drive signal at a first time toproduce a corresponding change in operating speed at a desired time. Thesecond period of time is greater than the first period of time.

The details of one or more implementations are set forth in theaccompanying drawings and the description below. Other features,objects, and advantages will be apparent from the description anddrawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a biventricular assist system including twoblood pumps.

FIG. 2 is a block diagram of the biventricular assist system.

FIG. 3 is a flow diagram of a process for controlling one of the bloodpumps based on blood flow.

FIG. 4 is a flow diagram of a process for controlling one of the bloodpumps based on a pulsatility index.

FIG. 5 is a flow diagram of a process for controlling both blood pumpsbased on two pulsatility indices and a heart rate.

FIG. 6 is a flow diagram of a process for controlling both blood pumpsbased on two pulsatility indices and blood flow.

FIGS. 7 to 11 are diagrams illustrating pump speed patterns forgenerating an artificial pulse.

FIG. 12 is a diagram of a computer system.

DETAILED DESCRIPTION OF THE INVENTION

In a system with two blood pumps, a controller dynamically adjusts thespeed of at least one of the pumps to maintain a relationship betweenthe blood flow through the pumps. As physiological conditions of thepatient change, the speed of at least one of the pumps is automaticallyadjusted to maintain the relationship. Additionally, the speed of theblood pumps can be adjusted to maintain a target load on one or bothventricles supported by the blood pumps.

Referring to FIG. 1, a biventricular assist system 10 for treating, forexample, a patient with a weakened left ventricle 12 and a weakenedright ventricle 14, includes a left blood pump 16 and a right blood pump18. The left blood pump 16 receives blood from the left ventricle 12 andsupplies blood to the patient's vasculature. The right blood pump 18receives blood from the right ventricle 14 and supplies blood to thepatient's pulmonary system. The pumps 16, 18 are operated by independentcontrol signals and can be independent units capable of being implantedseparately.

As an alternative to the configuration of FIG. 1, rather than supportweakened ventricles, the pumps 16, 18 can entirely replace the functionof the left and right ventricles, respectively. For example, one or bothof the ventricles can be removed, and the pump(s) can take over thefunction of the ventricle(s).

The pumps 16, 18 can be non-pulsatile pumps, for example, rotary pumpssuch as axial flow pumps or centrifugal pumps. In some implementations,one of the pumps is a centrifugal pump and the other pump is an axialflow pump. Each pump 16, 18 includes a motor. The motor speed of eachpump 16, 18, which corresponds to the pump speed, is the dominant factorthat affects blood flow through the pumps 16, 18. Thus the pump speeddetermines the level of support provided to the ventricles 12, 14 by thesystem 10. Also, as described further below, the pumps 16, 18 can benon-pulsatile pumps that are operated in an artificial pulse mode. Insuch case, the nature of the blood flow is a factor that affects thenature of support provided to the patient.

Referring to FIG. 2, the biventricular assist system 10 includes acontroller 20 that controls the operation of the left blood pump 16 andthe right blood pump 18. The controller 20 is implanted, for example, inthe patient's abdomen near the pumps 16, 18. Alternatively, thecontroller 20 can reside outside of the patient's body. The controller20 coordinates operation of the pumps 16, 18 and ensures that thecirculatory needs of the patient are met. For example, the controller 20sets the speed of each pump 16, 18 to provide a desired level ofcirculatory support. As physiological conditions of the patient change,the controller 20 varies the speed of the pumps 16, 18 to adjust thelevel of support provided. For example, the controller 20 increases thespeed of the pumps 16, 18 to increase circulatory support when needed,and decreases the speed of the pumps 16, 18 to avoid dangerousconditions, such as inducing suction in one of the ventricles 12, 14.

The controller 20 can be implemented as a single device separate fromthe pumps 16, 18, can be integrated into one of the pumps 16, 18, or thefunctions performed by the controller 20 can be distributed amongseveral different devices.

The controller 20 includes a processing unit 22 that calculates theappropriate speed for each pump 16, 18. The controller 20 includesmemory 24 that stores target operating parameters for the pumps 16, 18and results of calculations by the processing unit 22. The processingunit 22 can include one or more processing devices. The memory 24 alsostores executable instructions that, when executed by the processingunit 22, cause the controller 20 to perform the operations describedbelow, including calculating speeds for the pumps 16, 18 in response tochanging conditions. Alternatively, the processing unit 22 can includefixed-function logic that performs control operations.

Input to the controller 20 can be received through an input interface(not shown) which can provide an interface to receive data from sensors,the blood pumps 16, 18, and other devices. Output from the controller 20can be provided through an output interface (not shown) to, for example,a display or a computer system.

The controller 20 includes a speed control unit 26 that outputs controlsignals causing the pumps 16, 18 to operate at the speeds calculated bythe processing unit 22. The speed control unit 26 communicates with thepumps 16, 18 over communication links 32, 34, which carry power andcontrol signals. The speed control unit 26 varies a voltage or currentsupplied to the pumps 16, 18 to change the speed of the pumps 16, 18,which changes the flow of blood through the pumps 16, 18. The speedcontrol unit 26 also measures operating conditions of the pumps 16, 18,such as current speed, power consumption, electrical current draw, andback electromotive force (BEMF) of the pumps 16, 18, which theprocessing unit 22 uses to calculate blood flow through the pumps 16, 18and other operating parameters of the pumps 16, 18. The controller 20sets the speed of the pumps 16, 18 independently, for example, using adifferent control signal to set the speed of each pump 16, 18.

The power consumed by the pumps 16, 18 is proportional to the speed ofthe motor of the pumps 16, 18, and thus proportional to the blood flowthrough the pumps 16, 18. The processing unit 22 calculates blood flowthrough the pumps 16, 18 using the current draw, rotational speed, andempirical constants known for a particular pump. Changes in powerconsumption or current draw by the pumps 16, 18 indicate changes inblood flow through the pumps 16, 18.

The system 10 includes a heart rate sensor 40 to measure the heart rateof the patient, a left blood flow sensor 36 to measure blood flowthrough the left blood pump 16, and a right blood flow sensor 38 tomeasure blood flow through the right blood pump 18. The controller 20,in addition to, or instead of measuring blood flow using pump operatingdata, measures blood flow through the pumps 16, 18 using outputs of theblood flow sensors 36, 38. In some implementations, pressure sensors canbe included in addition to, or as an alternative to, the blood flowsensors 36, 38. Blood flow through the pumps 16, 18 can also becalculated based on the input of the pressure sensors.

The system 10 receives power from a power source 28, such as a batteryor power conversion unit. The power source 28 is located outside thepatient, and electrical power is transmitted to the system 10 through apercutaneous driveline 30 or through inductive coupling.

The controller 20 communicates with a clinical device 42 external to thepatient. The controller 20 and the clinical device communicate via atelemetric interface 44, which may be wired or wireless. In someimplementations, the telemetric interface 44 is integrated with thepercutaneous driveline 30. Using the clinical device 42, a clinician canaccess current and historical information about the operation of thesystem 10 from the memory 24, and can perform diagnostics for the system10.

Using the clinical device 42, the clinician can also input operatingparameters for the system 10, including target levels of support foreach of the ventricles 12, 14 as determined from examination of thepatient. The clinician can input, for example, a desired pump speed,blood flow, and/or pulsatility index for one or both of the pumps 16,18. The clinician can also select a control mode with which thecontroller 20 operates the pumps 16, 18, or enter new programming forthe controller 20.

The controller 20 controls the operation of the pumps 16, 18 accordingto one of several different control modes. Using any of the differentcontrol modes, the controller 20 automatically sets the speed of one orboth of the pumps 16, 18 to provide appropriate ventricular support asphysiological conditions of the patient change. The control modesinclude, for example, controlling one or more of the pumps 16, 18 basedon (1) blood flow through the pumps 16, 18, (2) a pulsatility index forone of the ventricles 12, 14, (3) a pulsatility index for each of theventricles 12, 14 and a heart rate, and (4) a pulsatility index for eachof the ventricles 12, 14 and blood flow through the pumps 16, 18. Forthe operation of the pumps 16, 18, both continuous operation andpulse-like operation modes can be implemented.

A pulse-like operation mode is also described below. The controller 20can generate an artificial pulse by modulating a rotor speed of one ofthe blood pumps 16, 18. In some implementations, the control of a pumpat a given time does not simultaneously include pulse-like operation anda control based on natural pulsatility of a ventricle 12, 14. Forinstance, the controller 20 can alternate control modes between thepulse mode and a continuous mode, or only one control mode can beselected for implementation. Implementation of pump control thatalternates between control modes may be chosen based on a condition ofthe patient. The control modes can be changed, for example, hourly,daily, weekly, monthly, or according to a period having any duration inlength ranging from minutes to weeks. Furthermore, it is possible toimplement a pulse mode for one VAD that operates simultaneously with acontinuous mode for another VAD. Moreover, if the ventricles arecompletely excised, either a fixed flow rate mode or a pulse mode ofoperation can be selected for either VAD.

In some implementations, both the pulsatility index control and theartificial pulse control are performed simultaneously. As describedfurther below, the artificial pulse can be generated without interferingwith the pulsatility index calculations. For example, the controller 20can exclude data collected near the time of an artificial pulseperturbation from the pulsatility index calculation.

Examples of non-pulsatile control modes are described below, followed byexamples of pulsatile control modes.

For each of the control modes described below, the controller 20 adjuststhe speed of each pump 16, 18 in increments, for example, by increasingor decreasing pump speeds by a set amount, such as 100 rotations perminute (rpm). In the processes described in FIGS. 3 to 6, when thecontroller 20 adjusts a pump speed, the pump speed is adjusted by oneincrement. Later repetitions of the processes, occurring periodically,can further adjust the pump speeds. By gradually adjusting the speedsover time, the controller 20 detects the response of the patient'scirculatory system and can prevent overcorrection of pump speeds.

The size of the increments can vary based on the characteristics of thepumps 16, 18, and the increments for the pumps 16, 18 can be different.The increments can be selected for each pump 16, 18 to effect aparticular change in blood flow, such as a change of 0.1 liters/minute(l/min). As an example, at a given pressure, a change of 0.1 l/min maycorrespond to a change of 100 rpm for a first pump, and a change of 300rpm for a second pump with different operating characteristics. Over therange of operation of the pumps 16, 18, the speed-flow response can begenerally linear, allowing for a consistent increment for each pump 16,18. In some implementations, the increments for each pump 16, 18 can bevaried over the operating range to compensate for a non-linear flowresponse.

Because the output pressure for the right blood pump 18 is lower thanthe output pressure for the left blood pump 16, the speed changeincrement to effect a particular change in blood flow for the rightblood pump 18 is typically less than the increment for the left bloodpump 16. Thus when the pumps 16, 18 have the same operatingcharacteristics, each incremental speed change for the left blood pump16 is typically larger than the incremental speed change for the rightblood pump 18.

To limit the risk of overpumping and suction, the controller 20decreases pump speeds more quickly than the controller 20 increases pumpspeeds. Accordingly, the speed adjustment increments to decrease pumpspeed are greater than the speed adjustment increments to increase pumpspeed. For example, the increment to increase a pump speed may be 75rpm, corresponding to a flow change 0.1 l/min, and the increment todecrease the pump speed may be 150 rpm, corresponding to a flow changeof 0.2 l/min.

In some implementations, as an alternative to incremental adjustment,the controller 20 adjusts the speeds of the pumps 16, 18 according toknown head and flow (HQ) characteristics of the pumps 16, 18 to reach adesired blood flow or blood pressure. The controller 20 calculates pumpspeeds to correspond to the desired blood flow or blood pressure andsets pumps 16, 18 to operate at the calculated speeds.

The controller 20 operates the pumps 16, 18 within a speed range, whichis selected separately for each pump 16, 18. The upper and lower limitsof the speed ranges are selected based on the prevailing condition ofthe patient's body and the patient's circulatory support needs.Typically, due to the higher output pressure facing the left blood pump16, when the pumps 16, 18 have the same operating characteristics, theleft blood pump 16 operates at speeds in a range higher than the rangein which the right blood pump 18 operates, although the ranges mayoverlap.

The controller 20 also performs calculations to detect and avoidoverpumping of the ventricles 12, 14, thus avoiding suction and/ordistending of the ventricles 12, 14. The controller 20 determines thepumping state of the ventricles 12, 14 based on, for example, measuredventricular pressure, pump blood flow, and/or a pulsatility index(described below) for the ventricle 12, 14. For example, the controller20 can detect and prevent suction of a ventricle using the techniquesdescribed in U.S. Pat. No. 6,991,595 and/or the techniques described inU.S. patent application Ser. No. 12/394,264, each of which isincorporated herein by reference in its entirety.

(1) Control Based on Blood Flow

In a flow-balancing control mode, the controller 20 sets the speed ofone of the pumps 16, 18 such that a predetermined relationship betweenblood flow through the pumps 16, 18 is maintained. The controller 20designates one of the pumps 16, 18 as a lead pump, and designates theother pump 16, 18 as a flow-balancing pump. The lead pump is operatedat, for example, a fixed speed selected to provide a desired level ofventricular support. The controller 20 sets the speed of theflow-balancing pump based on blood flow through the lead pump.

Because the speed of the flow-balancing pump is automatically adjustedby the controller 20, the system 10 responds to changes in blood flowthrough the lead pump without manual adjustment by a clinician. Thecontroller 20 also adjusts the speed of the flow-balancing pump whenphysiological conditions cause blood flow through the lead pump tochange. Regardless of the control mode selected for the lead pump, thecontroller 20 varies the speed of the flow-balancing pump to maintain apredetermined relationship between blood flow through the flow-balancingpump and blood flow through the lead pump.

By contrast, the controller 20 sets the speed of the lead pump using acontrol mode independent of the speed of the flow-balancing pump and theblood flow through the flow-balancing pump. For example, the controller20 may operate the lead pump at a fixed speed selected by a clinician.Alternatively, the controller 20 varies the speed of the lead pump suchthat blood flow through the lead pump is maintained at a target rate, orsuch that blood flow through the lead pump is maintained in a targetrange.

In some instances, if blood flow through the right blood pump 18 exceedsthe blood flow through the left blood pump 16 for a significant periodof time, blood can accumulate in the pulmonary system, causing the lungsto fill with fluid. To avoid this condition, known as pulmonary edema,the controller 20 can adjust the pump speeds such that, for example,blood flow through the left blood pump 16 (which is typically the leadpump) is greater than or equal to blood flow through the right bloodpump 18 (which is typically the flow-balancing pump). The controller 20can also set the pump speeds such that blood flow through the left bloodpump 16 is greater than blood flow through the right blood pump 18 by aparticular percentage, such as 10%, or a particular flow rate, such as1.0 liters/minute. Typically, these relationships can be maintainedregardless of which of the pumps 16, 18 operates as the lead pump or theflow-balancing pump.

In a normal heart, left ventricular output is typically greater thanright ventricular output by about 10%. While the cardiac outputsfluctuate, the total right cardiac output should generally be maintainedat or below about 90% of the total left cardiac output. In someimplementations, the cardiac outputs from the left ventricle 12 and theright ventricle 14 are assumed to be equal. As a result, the controller20 maintains blood flow through the right blood pump 18 at less than 90%of the blood flow through the left blood pump 16 to operate the system10 safely.

Referring to FIG. 3, the controller 20 performs a process 300 to set thespeed of the right blood pump 18, which, for instance, is designated asthe flow-balancing pump. Generally, the left blood pump 16 is thenoperated as the lead pump. The speed of the right blood pump 18 isincreased after blood flow through the left blood pump 16 has alreadyincreased, resulting in a low risk of blood flow increases above thedesired level due to an increase in pump speed.

At the beginning of the process 300, in step 302, the controller 20calculates blood flow through the left blood pump 16. In step 304, thecontroller 20 calculates blood flow through the right blood pump 18. Theblood flow through each of the pumps 16, 18 is determined as describedabove, for example, measured using input from the blood flow sensors 36,38 or calculated using rotational speed and current draw of the pumps16, 18. The controller 20 determines average blood flow over aninterval, such as 1 second, 5 seconds, or 15 seconds, and can alsodetermine an instantaneous blood flow rate. In some implementations,rather than calculating absolute blood flow through the pumps 16, 18,the controller 20 calculates a relative measure of the blood flow using,for example, the relative current draw of the pumps 16, 18.

In step 306, the controller 20 sets the speed of the right blood pump 18based on the blood flow through the left blood pump 16. For example, thecontroller 20 dynamically calculates a target blood flow for the rightblood pump 18 at, for example, 90% of the blood flow through the leftblood pump 16. The controller 20 then compares the target blood flow tothe calculated blood flow through the right blood pump 18, and adjuststhe speed of the right blood pump 18 up or down so that the target bloodflow is achieved. If the blood flow through the right blood pump 18 isless than the target blood flow, the controller 20 increases the speedof the right blood pump 18. By contrast, if the blood flow through theright blood pump 18 is greater than the target blood flow, thecontroller 20 decreases the speed of the right blood pump 18.

Rather than determining a target blood flow, the controller 20 maycompare the blood flow through the pump 16, 18 to determine whether apredetermined relationship is satisfied, for example, whether the bloodflow through the right blood pump 18 is less than or within a particularrange relative to the blood flow through the left blood pump 16. If thecontroller 20 determines that the relationship is not satisfied, thecontroller 20 adjusts the speed of the right blood pump 16 so that therelationship is achieved.

The controller 20 repeats the steps of the process 300 approximatelyonce each second to update the speed of the flow-balancing pump andmaintain the relative flow through the pumps 16, 18. In someimplementations, the controller 20 repeats the process 300 a differentperiodic rate, substantially continuously, in response to detectedchanges in blood flow, or based on a measured number of heartbeats.

In some implementations, the speed of the flow-balancing pump isadjusted in response to determining that blood flow through one of thepumps has changed, rather than determining that the desired relationshipbetween the flows is no longer satisfied. Thus the controller 20 canadjust the speed of the flow-balancing pump to maintain the desired flowrelationship, without requiring the relationship to be lost before anadjustment is made.

(2) Control Based on a Pulsatility Index

Using a pulsatility index control mode, the controller 20 sets the speedof one of the pumps 16, 18 such that the corresponding ventricle 12, 14experiences a desired load. The controller 20 designates one of thepumps 16, 18 as a lead pump, and adjusts the speed of the lead pump tomaintain a calculated pulsatility index, discussed below, at a targetlevel. As a result, the load on the ventricle remains substantiallyconsistent, even as physiological conditions change. The controller 20sets the speed of the other pump 16, 18 based on blood flow through thelead pump, using the flow balancing control mode described above.

The pulsatility of blood flow through a pump indicates the loadexperienced by a ventricle supported by the pump. Pulsatility refers tothe amount of variation in blood flow through the pump. The pumpexperiences varying input pressures during the cardiac cycle, resultingin varying blood flow through the pump. Strong contractions of theventricle result in large variations in blood flow during the cardiaccycle, or high pulsatility of blood flow through the pump. Weakcontractions result in lower variations in blood flow, or lowerpulsatility. High pulsatility indicates that a large amount of bloodflows out of the ventricle during systole due to a strong contraction,whereas low pulsatility indicates that a smaller amount of blood flowsout of the ventricle due to weak contraction.

The pulsatility of flow through the pump is correlated to the peakfilling of the ventricle during the cardiac cycle. The greater theexpansion and filling of a ventricle, the greater the force with whichthe ventricle contracts to eject the blood in the ventricle. Thus thepulsatility of flow through the pump, by indicating the force ofcontraction of the ventricle, also indicates the degree to which aventricle fills with blood.

The controller 20 calculates a pulsatility index that indicates thedifference between the maximum flow and the minimum flow through thepump during a particular time period. For example, the pulsatilityindex, PI, is be a dimensionless number calculated according to theequation, PI=(Q_(max)−Q_(min))/Q_(ave), where Q_(max) is a maximum flowrate through the pump in the period, Q_(min) is a minimum flow ratethrough the pump in the period, and Q_(ave) is an average flow ratethrough the pump over the period. The quantity Q_(ave) is calculated,for example, as the midpoint between Q_(max) and Q_(min), oralternatively as the total volume divided by the length of the timeperiod of interest.

The controller 20 uses the variation in current draw of the pump over acontrol interval to calculate the pulsatility index. Because the currentdraw of the pump is proportional to blood flow through the pump,variation in the current draw indicates the variation in blood flow.Alternatively, the controller 20 uses input from the blood flow sensorsto calculate the pulsatility index.

The controller 20 calculates the pulsatility index over a time periodcalled a control interval. The control interval has a duration of, forexample, one second, in which approximately one to two heartbeat cyclesoccur. The control interval can also be varied, for example, with thespeed of the heartbeat. The pulsatility index can be averaged overmultiple control intervals. The controller 20 stores previouspulsatility indices and generates an average of previously calculatedpulsatility indices, for example, an average of the pulsatility indicescalculated for the previous fifteen control intervals.

When a pump supporting a ventricle operates at a fixed speed, the pumpprovides a generally fixed degree of ventricular unloading. Ascirculatory needs of the patient increase and the pump speed remainsconstant, the ventricle becomes increasingly filled with blood,resulting in the ventricle experiencing an increased load because thepump does not remove a sufficient amount of blood from the ventricle.Without adjustment of the pump speed, the ventricle may fill excessivelybecause the ventricle is incapable of adjusting to the varyingphysiological conditions, for example, the ventricle may lack theability to achieve a contraction sufficient to eject the increasedamount of blood filling the ventricle.

To regulate the load on the ventricle, the controller 20 adjusts thespeed of the pump using the calculated pulsatility index and a targetpulsatility index. The target pulsatility index represents a desiredlevel of load for the ventricle. When circulatory demands increase,causing the calculated pulsatility index to exceed the targetpulsatility index, the controller 20 increases the speed of the pump toincrease support, thus decreasing the load experienced by the ventricleand reducing the pulsatility index. Similarly, when the pulsatilityindex is below the target level, the controller 20 decreases the speedof the pump to increase the load experienced by the ventricle and thusincrease the pulsatility index. Thus when physiological conditionschange, rather than allowing the load on the ventricle to increase ordecrease, the controller 20 adjusts the pump allow the load on theventricle to remain substantially consistent under differentphysiological conditions. Generally, increasing the speed of a pump willincrease ventricular unloading and thus reduce the pulsatility index. Bycontrast, decreasing the speed of a pump will permit increased loadingin the ventricle and thus increase the pulsatility index.

Referring to FIG. 4, the controller 20 performs a process 400 to controlthe left blood pump 16 as the lead pump based on a pulsatility index forthe left ventricle 12. Independent of the process 400, the controller 20also performs the process 300 (FIG. 3), setting the speed of the rightblood pump 18 based on blood flow through the left blood pump 16.Generally, as described above, the left blood pump 16 is operated as thelead pump to limit the risk of pulmonary edema.

Beginning the process 400, in step 402, the controller 20 calculates aleft pulsatility index, PI_(L), for the left ventricle 12, which is anaverage of the pulsatility indices corresponding to the previous 15control intervals. In step 404, the controller 20 determines whether theleft pulsatility index, PI_(L), is above a target pulsatility index,which corresponds to a particular load on the left ventricle 12. If thepulsatility index, PI_(L), is greater than the target pulsatility index,the left ventricle 12 is experiencing a greater load than desired. Inresponse, in step 406, the controller 20 increases the speed of the leftblood pump 16 to increase support to the left ventricle 12, ending theprocess 400. The speed of the left blood pump 16 is increased by a setincrement, such as 100 rpm. Increasing the speed of the left blood pump16 causes the left ventricle 12 to become less filled during subsequentcardiac cycles, decreasing the load experienced by the ventricle 12 andreducing the pulsatility index, PI_(L), toward the target pulsatilityindex.

If the controller 20 determines in step 404 that the left pulsatilityindex, PI_(L), is not greater than the target pulsatility index, thecontroller 20 determines in step 408 whether the left pulsatility index,PI_(L), is less than the target pulsatility index. If so, the left bloodpump 16 is providing excessive support, causing the left ventricle 12 tobe under-loaded. In response, the controller 20 decreases the speed ofthe left blood pump 16, ending the process 400. Decreasing the speed ofthe left blood pump 16 allows the left ventricle 12 to fill morecompletely and provide a greater portion of the circulatory output. Toreduce the risk of suction of the left ventricle 12, the controller 20decreases the speed in step 410 by a larger amount than the increase inspeed in step 406, for example, by 200 rpm.

In step 408, if the left pulsatility index, PI_(L), is not less than thetarget pulsatility index, the load experienced by the ventricle 12 andthe level of support provided by the left blood pump 16 are appropriate.The controller 20 maintains the current speed of the left blood pump 16,ending the process 400.

The controller 20 repeats the process 400 to adjust the support providedby the lead pump to meet to the changing needs of the patient. In someimplementations, the controller 20 performs the steps of the process 400at a particular interval, for example, every 15 seconds. In someimplementations, the pump speed is adjusted each time a pulsatilityindex for a control interval is calculated, using a running average ofcalculations for the previous 15 control intervals.

In some implementations, the controller 20 determines in step 404 andstep 406, whether the pulsatility index, PI_(L), is within a particulartolerance of the target pulsatility index. For example, the controller20 determines whether the pulsatility index, PI_(L), is within an upperor lower bound of a target pulsatility index range.

The techniques described can also be used to control the right bloodpump 18 as the lead pump, and to control the left blood pump 16 as aflow-balancing pump. In this configuration, the speed of the right bloodpump 18 is based on comparisons between a pulsatility index for theright ventricle 14 and a target pulsatility index for the rightventricle 14.

(3) Control Based on Two Pulsatility Indices and Heart Rate

Using a dual pulsatility index control mode, the controller 20 sets thespeeds of both of the pumps 16, 18 to regulate the loads experienced byboth ventricles 12, 14. The controller 20 adjusts the speeds of thepumps 16, 18 using a pulsatility index calculated for each ventricle 12,14 and a target pulsatility index for each ventricle 12, 14. Inaddition, the controller 20 adjusts the speeds of the pumps 16, 18 bycomparing a heart rate of the patient to a reference heart rate.

Referring to FIG. 5, the controller 20 sets the speeds of the pumps 16,18 by performing a process 500. In the process 500, the left blood pump16 is operated as the lead pump of the system 10, and the speed of bothpumps 16, 18 is adjusted based on the pulsatility indices for bothventricles 12, 14. The process 500 ends after the controller 20 adjuststhe pump speeds or determines that the current pump speeds should bemaintained. The process 500 is repeated to adjust the pumps asphysiological conditions change.

The controller 20 sets the speed of the pumps 16, 18 using (i) a rightpulsatility index, PI_(R), for the right ventricle 14 and (ii) a leftpulsatility index, PI_(L), for the left ventricle 12. The controller 20calculates the pulsatility indices, PI_(R), PI_(L), at the beginning ofthe process 500, or accesses the pulsatility indices, PI_(R), PI_(L),from stored values in the memory 24. The pulsatility indices, PI_(R),PI_(L), are averages of pulsatility index calculations for the 15 mostrecent control intervals.

The controller 20 stores (i) a target pulsatility index for the rightventricle 14, or right target, T_(R), and (ii) a target pulsatilityindex for the left ventricle 12, or left target, T_(L). The targets,T_(R), T_(L), indicate desired loads on the ventricles 12, 14, and inthe process 500, the controller 20 varies the pump speeds to achieve thedesired loads. Because the left blood pump 18 is the lead pump for theprocess 500, the left pulsatility index, PI_(L), and the left target,T_(L), influence the control of the system 10 to a greater degree thanthe right pulsatility index, PI_(R), and the right target, T_(R). Forexample, the system 10 is controlled with a higher priority to achievethe left target, T_(L), than to achieve the right target, T_(R). Inaddition, the speed of the left pump 16 can be increased or decreasedwithout a corresponding change in the speed of the right pump 18. Thespeed of the right pump 18, however, changes only when the speed of theleft pump 16 changes.

Beginning the process 500, in step 502, the controller 20 determineswhether the left pulsatility index, PI_(L), exceeds the left target,T_(L). If so, the controller 20 determines in step 504 whether the rightpulsatility index, PI_(R), is greater than the right target, T_(R). Ifso, then the system 10 is providing insufficient support to bothventricles 12, 14. As a result, in step 506 the controller 20 increasesthe speed of the left blood pump 16 and increases the speed of the rightblood pump 18. Increasing the pump speeds off-loads the ventricles 12,14 further and causes the pulsatility indices, PI_(R), PI_(L), todecrease toward the targets, T_(R), T_(L).

Returning to step 504, if the right pulsatility index, PI_(R), is notgreater than the right target, T_(R), the controller 20 increases thespeed of the left blood pump 16 in step 510, increasing support to theleft ventricle 12. Increased support is needed because, as determined instep 502, the left pulsatility index, PI_(L), exceeds the left target,T_(L), indicating overloading of the left ventricle 12. By increasingthe speed of the left blood pump 16, the load on the left ventricle isreduced and the pulsatility index, PI_(L), decreases toward the targetlevel, T_(L).

Returning to step 502, if the left pulsatility index, PI_(L), is greaterthan the left target, T_(L), the controller 20 determines in step 512whether the right pulsatility index, PI_(R), is greater than the righttarget, T_(R). If so, then the controller 20 decreases the speed of theleft blood pump 16 in step 514. When entering step 514, the leftpulsatility index, PI_(L), is known to be at or below the left target,T_(L), as determined in step 502. By decreasing the speed of the leftblood pump 16, support for the left ventricle 12 is reduced, allowingthe left pulsatility index, PI_(L), to increase over subsequentcalculations. Because the right ventricle 14 remains overloaded when theleft ventricle 12 is under-loaded, it is assumed that reducing the speedof the left blood pump 16 to avoid left ventricular suction will notsignificantly affect the loading of the right ventricle 14.

If the outcome of step 512 is negative, the controller 20 determines instep 516 whether the right pulsatility index, PI_(R), is less than theright target, T_(R). If not, then the right ventricle 14 is experiencingan appropriate load, the controller 20 maintains the current speeds ofthe pumps 16, 18. If, however, the right pulsatility index, PI_(R), isless than the right target, T_(R), the controller 20 continues to step518.

Entering step 518, comparisons between the pulsatility indices, PI_(R),PI_(L), and the targets, T_(R), T_(L), indicate that both ventricles 12,14 are under-loaded, suggesting that support for the ventricles 12, 14should be decreased. Nevertheless, the needs of the patient are notalways fully indicated by the pulsatility indices, PI_(R), PI_(L). Forexample, when the patient begins to exercise, the patient's heart rateincreases but the ventricles 12, 14 do not immediately expand. Net bloodflow through the ventricles 12, 14 increases as the heart rateincreases, but the pulsatility indices, PI_(R), PI_(L), for the pumps16, 18 initially decrease. As the patient's needs for support areincreasing due to the increased exertion, it is undesirable to decreaseventricular support.

To distinguish between actual under-loading of the ventricles 12, 14 andfalse indications of under-loading, the controller 20 compares ameasured heart rate of the patient to a reference heart rate. Thereference rate target is set at a level higher than a resting heart rateor an average heart rate for the patient. For example, the referenceheart rate is set at an offset above a resting heart rate of the patientby a particular percentage, such as 10%, or a particular amount, such 10beats per minute. In some implementations, the reference heart rate canbe set based on a running average of the patient's heart rate over atime period. A baseline heart rate can be determined as an average rateover, for example, the previous hour, and the reference heart rate, forinstance, can be set as an offset of 10 or 15 beats per minute above thebaseline rate.

When the heart rate is above the reference rate, the exertion of thepatient is likely above average, and the ventricular support should notbe decreased. Thus when the controller 20 determines in step 518 thatthe patient's heart rate is above the reference rate the controller 20maintains the speeds of the pumps 16, 18.

By contrast, when the heart rate is below the reference rate in step518, the patient is most likely not exercising, and the ventricles 12,14 are most likely under-loaded because the pumps 16, 18 are drawing toomuch blood from the ventricles 12, 14. As a result, the controller 20continues to step 520 and decreases the speeds of both of the pumps 16,18, allowing the loads experienced by the ventricles 12, 14 to increase.

The controller 20 repeats the process 500, adjusting the speeds of thepumps 16, 18 in response to changing physiological conditions. Thecontroller 20 recalculates the pulsatility indices, PI_(R), PI_(L), andrepeats the process 500 periodically to allow the patient's circulatorysystem to respond to the changes in ventricular support. Alternatively,the controller 20 repeats the process substantially continuously or asnew values for the pulsatility indices, PI_(R), PI_(L), are calculated.

The process 500 is summarized as a set of control rules in Table 1,below. Table 1 includes columns indicating conditions for (i) the leftpulsatility index, PI_(L), (ii) the right pulsatility index, PI_(R), and(iii) the heart rate of the patient. Table 1 also includes a column ofactions performed by the controller 20 in response to the conditions ineach row. The controller 20 performs the action in a given row of Table1 when the conditions in the row are determined to be present.

TABLE 1 Control Rules for the Left Blood Pump 16 as Lead Pump (Process500) Left Pulsatility Right Pulsatility Index (PI_(L)): Index (PI_(R)):Heart Rate: Action Above Left Above Right (any value) Increase thespeeds of Target (T_(L)) Target (T_(R)) both pumps 16, 18 Above Left Ator Below (any value) Increase the speed of Target (T_(L)) Right Target(T_(R)) the left blood pump 16 Below Left Above Right (any value)Decrease the speed of Target (T_(L)) Target (T_(R)) the left blood pump16 Below Left At Right Target (any value) Maintain current speeds Target(T_(L)) (T_(R)) of both pumps 16, 18 Below Left Below Right BelowDecrease the speeds Target (T_(L)) Target (T_(R)) Reference of bothpumps 16, 18 Heart Rate Below Left Below Right Above Maintain currentspeeds Target (T_(L)) Target (T_(R)) Reference of both pumps 16, 18Heart Rate

The controller 20 can also set the speeds of the pumps 16, 18 with theright blood pump 18 designated as the lead pump, using the control rulesdescribed in Table 2, below.

TABLE 2 Control Rules for the Right Blood Pump 18 as Lead Pump RightPulsatility Left Pulsatility Index (PI_(R)) is: Index (PI_(L)) is: HeartRate is: Action Above Right Above Left (any value) Increase the speedsof Target (T_(R)) Target (T_(L)) both pumps 16, 18 Above Right At orBelow Left (any value) Increase the speed of Target (T_(R)) Target(T_(L)) the right blood pump 18 Below Right Above Left (any value)Decrease the speed of Target (T_(R)) Target (T_(L)) the right blood pump18 Below Right At Left Target (any value) Maintain current speeds Target(T_(R)) (T_(L)) of both pumps 16, 18 Below Right Below Left BelowDecrease the speeds of Target (T_(R)) Target (T_(L)) Reference bothpumps 16, 18 Heart Rate Below Right Below Left Above Maintain currentspeeds Target (T_(R)) Target (T_(L)) Reference of both pumps 16, 18Heart Rate

(4) Control Based on Two Pulsatility Indices and Blood Flow

Referring to FIG. 6, the controller 20 performs a process 600 thatimplements an alternative control mode using the pulsatility indices,PI_(R), PI_(L), calculated for each ventricle 12, 14. Rather thancomparing a heart rate to a reference heart rate, however, thecontroller 20 compares measured blood flow to a target blood flow tomaintain a generally constant blood flow through the lead pump whileregulating the load on the ventricles 12, 14.

In the process 600, the left blood pump 16 is operated as the lead pump.The pulsatility indices, PI_(R), PI_(L), are calculated and the targets,T_(R), T_(L), are set as described above for the process 500. Thecontroller 20 additionally stores a target blood flow for the rightblood pump 16.

The process 600 includes many of the same steps as the process 500. Inthe process 600, however, the step 518 of the process 500 for comparinga heart rate to a reference rate is replaced with step 602, in whichblood flow through the lead pump 18 is compared to the target bloodflow. The process 600 also includes an additional step 604, betweensteps 504 and 506, in which blood flow through the lead pump 18 iscompared to the target blood flow.

At the point in the process 600 when step 602 is reached, both of thepulsatility indices, PI_(R), PI_(L), have been determined to be belowtheir respective targets, T_(R), T_(L). Under these conditions, if bloodflow through the left blood pump 16 is greater than the target bloodflow, support for the ventricles 12, 14 should be reduced. Thecontroller 20 reduces the speed of both blood pumps 16, 18, allowing thepulsatility indices, PI_(R), PI_(L), to rise toward the levels indicatedby the targets, T_(R), T_(L), and reducing the potential of ventricularsuction due to excessive unloading. In addition, reducing the speed ofthe pumps 16, 18 allows the blood flow through the left pump to decreasetoward the target blood flow level.

By contrast, if blood flow through the left blood pump 16 is determinedto be at or below the target blood flow, the speed of the pumps 16, 18should not be reduced, because a reduction in speed would cause theblood flow through the left blood pump to decrease. The controller 20maintains the speed of the pumps 16, 18 so that the current blood flowthrough the left pump 16 is maintained.

Referring now to step 604, when both ventricles 12, 14 experience ahigher than desired load, the controller 20 compares the blood flowthrough the left blood pump 16 to the target blood flow. Step 604 isreached when the right pulsatility index, PI_(R), exceeds the righttarget, T_(R), and the left pulsatility index, PI_(L), exceeds the lefttarget, T_(L). If the blood flow through the left blood pump 16 is lessthan the target blood flow, the controller 20 increases the speeds ofboth pumps 16, 18 to increase support to both ventricles 12, 14 andincrease the blood flow through the left pump 16.

If blood flow through the left blood pump 16 is not less than the targetblood flow, the controller determines in step 602 whether blood flowthrough the left blood pump 16 is greater than the target blood flow. Ifblood flow through the left blood pump 16 is greater than the targetblood flow, the controller 20 reduces the speed of the pumps 16, 18. Ifnot, the flow through the left blood pump 16 is at the target blood flowlevel, and the controller 20 maintains the current speed of the pumps16, 18.

The controller 20 repeats the process 600, adjusting the speeds of thepumps 16, 18 in response to changing physiological conditions. Forexample, the controller 20 recalculates the pulsatility indices, PI_(R),PI_(L), and repeats the process 600 approximately once each second asnew values for the pulsatility indices, PI_(R), PI_(L), are calculated.The process 600 can also be repeated at other intervals or performedsubstantially continuously.

In some implementations, the target blood flow is a moving average ofblood flow over a particular interval rather than a fixed value. As aresult, comparisons to the target blood flow indicate whether blood flowthrough the pump is increasing or decreasing. In step 602, for example,increasing blood flow through the left blood pump 16 is increasing canbe a strong indication that the patient's level of activity isincreasing, and thus that the speeds of the pumps 16, 18 should bemaintained.

In some implementations, the blood flow through the right blood pump 18is compared to a target blood flow, in addition to or instead ofcomparing blood flow through the left blood pump 16. The decisions insteps 602 and 604 can be based on blood flow through both pumps 16, 18to achieve a target blood flow for the right blood pump 16 and a targetblood flow for the left blood pump 16. For example, in step 602 the pumpspeeds can be maintained when either or both of the blood flows throughthe pumps 16, 18 are at or below their respective target blood flow.

The process 600 can be modified to additionally adjust the pump speedsbased on measured a heart rate. The heart rate and blood flow cantogether be compared to target values to determine whether the patient'sneed for ventricular support is increasing. For example, in step 602,the controller 20 can determine whether the heart rate is above areference rate and whether blood flow through one or both of the pumps16, 18 is above the target blood flow. In some implementations, in step602, the controller 20 maintains the current pump speeds unless theheart rate is below the reference rate and the blood flow is above thetarget blood flow, in which case the pump speeds are decreased.

The process 600 is summarized as a set of control rules in Table 3,below. Table 3 includes columns indicating conditions for (i) the leftpulsatility index, PI_(L), (ii) the right pulsatility index, PI_(R), and(iii) the blood flow through the left blood pump 16. Table 3 alsoincludes a column of actions performed by the controller 20 in responseto the conditions in each row.

TABLE 3 Control Rules for the Left Blood Pump 16 as Lead Pump (Process600) Blood Flow Left Pulsatility Right Pulsatility through left Index(PI_(L)) is: Index (PI_(R)) is: pump 16 is: Action Above Left AboveRight At Blood Flow Maintain current Target (T_(L)) Target (T_(R))Target Level speeds of both pumps 16, 18 Above Left Above Right AboveBlood Decrease the Target (T_(L)) Target (T_(R)) Flow Target speeds ofboth Level pumps 16, 18 Above Left Above Right Below Blood Increase theTarget (T_(L)) Target (T_(R)) Flow Target speeds of both Level pumps 16,18 Above Left At or Below (any value) Increase the Target (T_(L)) RightTarget (T_(R)) speed of the left blood pump 16 Below Left Above Right(any value) Decrease the Target (T_(L)) Target (T_(R)) speed of the leftblood pump 16 Below Left At Right (any value) Maintain current Target(T_(L)) Target (T_(R)) speeds of both pumps 16, 18 Below Left BelowRight Above Blood Decrease the Target (T_(L)) Target (T_(R)) Flow Targetspeeds of both Level pumps 16, 18 Below Left Below Right At or BelowMaintain current Target (T_(L)) Target (T_(R)) Blood Flow speeds of bothTarget Level pumps 16, 18

The controller 20 can also set the speeds of the pumps 16, 18 with theright blood pump 18 designated as the lead pump, using the control rulesdescribed in Table 4, below.

TABLE 4 Control Rules for the Right Blood Pump 18 as Lead Pump BloodFlow Right Pulsatility Left Pulsatility through right Index (PI_(R)) is:Index (PI_(L)) is: pump 18 is: Action Above Right Above Left At BloodFlow Maintain current speeds Target (T_(R)) Target (T_(L)) Target Levelof both pumps 16, 18 Above Right Above Left Above Blood Decrease thespeeds Target (T_(R)) Target (T_(L)) Flow Target of both pumps 16, 18Level Above Right Above Left Below Blood Increase the speed of Target(T_(R)) Target (T_(L)) Flow Target both pumps 16, 18 Level Above RightAt or Below (any value) Increase the speed of Target (T_(R)) Left theright blood pump 18 Target (T_(L)) Below Right Above Left (any value)Decrease the speed of Target (T_(R)) Target (T_(L)) the right blood pump18 Below Right At Left (any value) Maintain current speeds Target(T_(R)) Target (T_(L)) of both pumps 16, 18 Below Right Below Left AboveBlood Decrease the speeds Target (T_(R)) Target (T_(L)) Flow Target ofboth pumps 16, 18 Level Below Right Below Left At or Below Maintaincurrent speeds Target (T_(R)) Target (T_(L)) Blood Flow of both pumps16, 18 Target Level

Any of the four control modes described above can be used to control thepumps 16, 18 of the system 10 when the pumps 16, 18 are configured tosupport the ventricles 12, 14. When the pumps 16, 18 are configured toreplace the right and left ventricles of a heart, however, only the flowbalancing control mode is used. Without pulsating ventricles to providevarying input pressures to the pumps 16, 18, there is no variation offlow through the pumps 16, 18. As a result, pulsatility indices cannotbe used as control parameters for the system 10 when the pumps 16, 18replace the ventricles completely.

In some implementations, control can be implemented such that the leftblood pump 16 and the right blood pump 18 operate independently unlessthe overpumping of a ventricle 12, 14 occurs. For example, each pump 16,18 is operated a fixed speed or based on a pulsatility index withoutfeedback between the pumps 16, 18. If overpumping occurs, which may leadto suction and serious disruptions of overall blood flow, control of theright blood pump 18 becomes limited based on the operation of the leftblood pump 16.

In addition to, or as an alternative to, the techniques described above,the maximum speed of the right blood pump 18 can be limited so that theright blood pump cannot generate excessive outlet pressures that couldcause pulmonary edema.

In some implementations, one or both of the pumps 16, 18 may be operatedfor periods of time to produce a pulsatile flow, as described below. Forexample, the operating speeds of the pumps 16, 18 can be varied in amanner that generates or intensifies a pulsatile flow through the pumps16, 18.

The controller 20 can control one of the pumps 16, 18 to produce anartificial pulse where operation at a fixed or constant speed isdescribed above. Control modes that induce an artificial pulsatile flowcan be used in an alternating sequence with control modes that usepulsatility index calculations. As an example, the controller 20 cancontrol one or both of the pumps 16, 18 in a manner that alternatesbetween periods of pulsatile control and periods of control thatgenerate substantially continuous flow. For example, the controller 20can operate one or both of the pumps 16, 18 to generate a pulsatile flowduring a first period. The controller 20 can then operate one or both ofthe pumps 16, 18 based on pulsatility index calculations or blood flowduring a second period. The controller 20 alternates between thedifferent control modes at predetermined intervals. The period of timethat each control mode is active can have a predetermined duration.

In some implementations, the controller 20 operates one of the pumps 16,18 to generate a pulsatile flow while operating the other pump 16, 18 togenerate a substantially continuous flow. Substantially continuous flowcan be generated using a control mode based on blood flow or a controlmode based on pulsatility index calculations for a ventricle supportedby the pump 16, 18 operated to generate the continuous flow. As anexample, the controller 20 can operate one of the pumps 16, 18 using apulsatile flow control mode, as described further below. The controller20 can simultaneously operate the other pump 16, 18 such that apredetermined relationship between blood flow through the pumps 16, 18is maintained, using the techniques described above.

Various characteristics of the artificial pulse may differ substantiallyfrom those of a physiologic pulse even while producing a response in thebody that is similar to that caused by the physiologic pulse. It isgenerally understood that the dominant source of dissipated energy thatcharacterizes a meaningful pulse is the pressure wave generated at thestart of cardiac systole. Accordingly, the artificial pulse describedherein can include a relatively brief perturbation of a nature designedto produce such dissipated energy.

In some implementations, an artificial pulse cycle includes aperturbation period that simulates the pulse pressure that occurs at theleading edge of systole of a physiologic pulse. The perturbation periodcan include, for example, a period during which the blood pump 16 isoperated at a low speed, followed immediately by a period during whichthe blood pump 16 is operated at a higher speed. The artificial pulsecycle can also include a period longer than the perturbation periodduring which the pump 16 is operated at an intermediate speed, forexample, a speed maintained between the speeds realized during theperturbation period.

Operating the pump at the intermediate speed can contribute to a highoperating efficiency. The efficiency achieved can be greater than, forexample, the efficiency of a pump that only alternates between equalperiods of operation at a high speed and at a low speed. Typically, acontinuous flow pump operates with highest efficiency near the middle ofits rotational speed range. Therefore, it can be advantageous to operatesuch a pump at or near a mid-range speed for at least a portion of anartificial pulse cycle.

Some of the parameters that affect physiologic phenomena include pulsepressure and the rate of blood pressure change (dp/dt). For the bloodpump 16, for example, pulse pressure and time variation in bloodpressure are affected by the angular velocity of the rotor. Thus, theblood pump 16 can be selectively controlled to produce a pulsatile bloodflow pattern, including a desired pulse pressure and/or a desired rateof pressure change, by producing a pump speed pattern that includes atime period of relatively high rotor rotation speeds and a time periodof relatively low rotor rotation speeds. In some implementations, thepulse pressure produced by the blood pump 16 or produced by the bloodpump 16 and the patient's heart in combination can be approximately 10mmHg or more, such as from approximately 20 mmHg to approximately 40mmHg.

For example, the blood pump 16 can be operated to produce a pump speedpattern 700, illustrated in FIG. 7. The pump speed pattern 700 includesa first portion 710 with high pump speed producing a relatively highblood pressure, and a second portion 720 with low pump speed producing arelatively low blood pressure. Additionally, the pulsatile blood flowpattern can include a transition between the first portion 710 and thesecond portion 720 that produces a desired rate of pressure change inthe patient's circulatory system, such as a rate of pressure change thatsimulates a natural physiologic pulse and that produces desiredphysiological effects associated with rate of pressure change. In someimplementations, the rate of pressure change produced by the transitionis, for example, between 500 mmHg to 1000 mmHg per second.

The first portion 710 and/or the second portion 720 of the pump speedpattern 700 can include multiple segments. In some implementations, thesegments each have predetermined durations. As also shown in FIG. 7, thefirst high speed portion 710 of the pump speed pattern 700 includes afirst segment 710 a and a second segment 710 b. In the first segment 710a, the rotor is rotated at a first rotation speed ω1 for a first periodof time from a time T0 to a time T1. At the time T1, the rotation speedof the rotor is rapidly decreased from the first rotation speed ω1 to asecond rotation speed ω2, producing a stepped transition. The rotor isrotated at the second rotation speed ω2 for a second period of time fromthe time T1 to a time T2 during a second segment 710 b of the firstportion 710 of the pump speed pattern 700. At the time T2, the rotationspeed of the rotor is decreased to a third rotation speed ω3 for a thirdperiod of time from the time T2 to a time T4 during the second portion720 of the pump speed pattern 700. This speed decrease may be as rapidas the aforementioned speed increase, or more gradual to mimic pressurechanges during native diastole.

In the pump speed pattern 700, the second rotation speed ω2 is a targethigh blood flow pump speed, and the first rotation speed ω1 is a desiredovershoot pump speed that is selected to increase the rate of change ofthe blood pressure during the first period. The first period of timefrom the time T0 to the time T1, during which the blood pump 16 isoperated at the first rotation speed ω1, is shorter than the secondperiod of time from the time T1 to the time T2, during which the bloodpump 16 is operated at the second rotation speed ω2. The first period oftime can be from approximately 0.01 seconds to approximately 1 second.In some implementations, the first period of time is approximately 0.05seconds in duration. In some implementations, the first period of timecan be approximately equal to, or greater than the second period oftime.

Additionally, the duration of the first period can be selected toproduce a desired pulse pressure, i.e., the difference between bloodpressure before the speed change time T1 and during the time T1, and canbe selected independently of the duration of the second period of time.The first portion 710, including the first and second time periods fromthe time T0 to the time T2, is longer than the second portion 720. Insome implementations, the first and second time periods from the time T0to the time T2 can be shorter than, longer than, or substantially thesame duration as the second portion 720. For example, to increase theduration of pumping at the higher flow rate relative to pumping at thelower rate while still benefiting from the occasional pulse, it may beadvantageous for the first portion 710 to be longer than the secondportion 720. If desired, the speed of the blood pump 16 is increased tothe first rotation speed ω1 and the pump speed pattern 700 can berepeated. The pump speed pattern 700 can be repeated on a continuous ordiscontinuous basis, and the increase of rotation speed of the rotor isalso sufficiently rapid to produce a desired rate of pressure change.

The concept of overshooting the rotation speed ω2 with a greater speed,such as rotation speed ω1, is based upon partly decoupling pulsepressure, i.e. the difference between the blood pressures before andafter the speed change, from the volume flow rate at the higher speed.Thus, target pulse pressures and volume flow rates can be attained atvarious flow conditions. Ideal values will vary with particular pumpdesign and requirements.

As shown in FIG. 7, the period 710 b can be longer than the period 710a. The period 710 b can also be longer than the portion 720. In someimplementations, the duration of the period 710 b is more than half ofthe duration of the pump speed pattern 700. For example, the duration ofthe period 710 b can be 60%, 70%, 80% or more of the duration of thepump speed pattern 700. As an alternative, depending on patient needsand pump characteristics, the duration of the period 710 b can be 50% orless of the duration of the pump speed pattern 700, for example, 40%,30%, 20% or less.

Operating the pump at the rotation speed ω2 during the period 710 b cancontribute to a high hydraulic efficiency during the pump speed pattern700. During the pump speed pattern 700, the pulse pressure generated ina patient's body is generally correlated to the change in pump rotationspeed, for example the magnitude of the speed change between the speedsω3 and ω1 at time T4. Therefore, to simulate a pressure change thatoccurs at the beginning of systole of a physiologic pulse, a significantspeed differential between the rotation speeds ω3 and ω1 is generallydesired. The speed differential can be, for example, 1000 rpm, 2000 rpm,or more depending on the characteristics of the blood pump 16. Due tothe magnitude of the speed differential, one or both of the speeds ω3 toω1 may occur outside the range of highest operating efficiency of theblood pump 16.

The rotation speed ω2 can be a speed that results in a high hydraulicefficiency of the blood pump 16, for example, a speed near the middle ofthe operating range of the blood pump 16. During the pump speed pattern700, the blood pump 16 can operate at the speed ω2 that results in highefficiency for a significant portion of the pump speed pattern 700,contributing to a high efficiency. As described above, the blood pump 16can operate at the speed ω2 for more than half of the duration at thepump speed pattern 700. Thus the blood pump 16 can operate in a highlyefficient manner for the majority of the pump speed pattern 700 and canalso produce a pressure change that simulates the beginning of systoleof a physiologic heart. Accordingly, some implementations of the pumpspeed pattern 700 can provide a higher efficiency than control modesthat attempt to mimic all aspects of a native cardiac cycle.

The length of the period 710 b relative to the length of the pump speedpattern 700 can vary based on the frequency of the artificial pulse. Theduration of the period 710 a and of the portion 720, by contrast, can beindependent of the pulse rate. To produce the desired physiologicalresponse, a minimum duration for the period 710 a and the portion 720can be selected, for example, 0.125 seconds. The period 710 b can fillthe remainder of the pump speed pattern 700.

As an example, the pump speed pattern 700 can have a duration of onesecond, for a frequency of 60 cycles per minute. Given that the period710 a and the portion 720 have a combined duration of 0.125 seconds, theperiod 710 b can have a duration of 0.750 seconds, or 75% of the pumpspeed pattern 700. As another example, when the pump speed pattern 700has a duration of two seconds (and thus a frequency of 30 cycles perminute), the duration of the period 710 b can be 1.75 seconds, which is87.5% of the duration of the pump speed pattern 700.

In some implementations, the rotation speed ω2 is selected such that theoperation of the blood pump 16 at the rotation speed ω2 produces a flowrate that has a predetermined relationship relative to the average flowrate during the pump speed pattern 700. The flow rate during the portion710 b can be within a predefined range of the average flow rate, forexample, within 30% or within 10% of the average flow rate. The flowrate during the portion 710 b can be substantially equal to the averageflow rate.

Selecting the rotation speed ω2 to produce a flow rate that issubstantially equal to the average flow rate can facilitate a transitionbetween a pulsatile control mode and another control mode, such as acontinuous flow control mode. In some implementations, the blood pump 16operates at a particular constant speed for the greater part of the pumpspeed pattern 700. Operation at the constant speed can occur during, forexample, the period 710 b. By adjusting the speeds ω1 and ω3 andduration of the period 710 a and of the portion 720, the average pumpvolume flow rate can be tuned to substantially match an average pumpvolume flow rate that would be realized in a different optional setting.Consequently, a clinician or patient can switch from an artificial pulsemode to another control mode in a manner that causes only a smalldifference or no difference in average volume flow rate. This canprovide a clinical advantage when the artificial pulse is a selectableoption among at least one alternative, for example, a constant speedoption.

As an example, a speed set by a clinician for a constant speed mode canalso be utilized for a constant speed portion of an artificial pulsemode. The speed can be selected by the clinician to produce a desiredvolume flow rate through the blood pump 16 during the constant speedmode (e.g., during continuous flow or non-pulsatile operation of theblood pump 16). In the artificial pulse mode, the same selected speedcan be used as, for example, the rotation speed ω2 during the period 710b of the pump speed pattern 700. The speeds ω1, ω3 and the duration ofthe period 710 a and the portion 720 are calculated or chosen toapproximately balance the volume flow rate for the pump speed pattern700. For example, the reduced flow rate during the portion 720 canoffset the increased flow rate during the portion 710 a. As a result,the net volume flow rate during the pump speed pattern 700 cansubstantially match the volume flow rate during the constant speed mode.Thus in either the constant speed mode or the artificial pulse mode, thevolume flow rate can be approximately the same, permitting the clinicianto switch from one mode to another without affecting the volume flowrate. This can help avoid potentially dangerous conditions that couldoccur if switching from one mode to another resulted in sudden changesin flow rate. For example, a sudden decrease in volume flow rate couldcause acutely insufficient perfusion for the patient, and a suddenincrease in volume flow rate could cause ventricular suction andarrhythmia.

As mentioned above, the second portion 710 of the pump speed pattern 700can also include multiple segments. For example, as shown in FIG. 8, apump speed pattern 800 includes a first portion 810 that has a firstsegment 810 a and a second segment 810 b and the pump speed pattern 800includes a second portion 820 that has a first segment 820 a and asecond segment 820 b. During the first segment 810 a, from the time T0to the time T1, the blood pump 16 is operated at the first rotationspeed ω1. At the time T1, the speed of the blood pump 16 is reduced tothe second rotation speed ω2, and the blood pump 16 is operated at thesecond rotation speed ω2 for the second period of time from the time T1to the time T2. At the time T2, the speed of the blood pump 16 isreduced from the second speed ω2 to the third rotation speed ω3. Theblood pump 16 is operated at the third rotation speed ω3 for a thirdperiod of time from the time T2 to a time T3 during a first segment 820a of the second portion 820 of the pump speed pattern 800. At the timeT3, the speed of the blood pump 16 is increased from the third rotationspeed ω3 to a fourth rotation speed ω4, and the blood pump 16 isoperated at the fourth rotation speed ω4 during a fourth period of timefrom the time T3 to the time T4 during a second segment 820 b of thesecond portion 820 of the pump speed pattern 800. If desired, the speedof the blood pump 16 is increased to the first rotation speed ω1 and thepump speed pattern 800 can be repeated. The pump speed pattern 800 canbe repeated on a continuous or discontinuous basis, and the increase ofrotation speed of the rotor is also sufficiently rapid to produce adesired rate of pressure change.

Similar to the concept of overshooting ω2 in pattern 700, the concept ofovershooting the rotation speed ω4 with a lower rotation speed, such asthe rotation speed ω3, is also based upon decoupling pulse pressure fromthe volume flow rate at the lower rotation speed ω4. Thus, the pumpspeed pattern 800 more completely decouples target pulse pressures andvolume flow rates than the pump speed pattern 700, and ideal values canbe attained, or more closely approximated, at various flow conditions.

While a single overshoot pump speed for a transition between pump speedsare illustrated and described with reference to FIGS. 7 and 8, multipleovershoot pump speeds for one or more transitions can be used. Forexample, FIG. 9 illustrates a pump speed pattern 900 that includesmultiple overshoot pump speeds for each transition. The pump speedpattern 900 includes a first portion 910 having a first segment 910 aand a second segment 910 b, and that includes a second portion 920having a first segment 920 a and a second segment 920 b. The firstsegment 910 a of the first portion 910 of the pump speed pattern 900includes a first step 931 during which the blood pump 16 is operated atthe first rotation speed ω1 to overshoot the target pump speed ω2 and asecond transition step 433 during which time the blood pump 16 isoperated at a fifth speed ω5 to transition from the first rotation speedω1 to the second rotation speed ω2. Similarly, the first segment 920 aof the second portion 920 includes a first step 941 during which theblood pump 16 is operated at the third rotation speed ω3 and a secondsegment 443 during which the blood pump 16 is operated at a sixth speedω6 to transition between the third speed ω3 and the fourth rotationspeed ω4. If desired, the speed of the blood pump 16 is increased to thefirst rotation speed ω1 and the pump speed pattern 900 can be repeated.The pump speed pattern 900 can be repeated on a continuous ordiscontinuous basis, and the increase of rotation speed of the rotor isalso sufficiently rapid to produce a desired rate of pressure change.

The concept of creating multiple stepwise rotation speed changes isbased upon producing the physiologic response that is similar to thatproduced during human cardiac systole and diastole. This is distinctfrom mimicking the nature of a native pulse waveform in its entirety. Asdescribed above, greater hydraulic efficiency can often be achieved byavoiding imitation of the physiologic pressure waveform over the pulsecycle. It was previously mentioned that an artificial pulse offers amultitude of potential clinical advantages. For some or all of thesepotential clinical advantages, the benefit of closely matching theenergy dissipated during a healthy native pulse varies. To the extentthat close matching facilitates achieving these potential clinicaladvantages, the additional complexity of pattern 900 may be warranted.

In contrast to the stepped or discontinuous transitions discussed abovewith respect to FIGS. 7 to 9, smooth or continuous transitions may beused in place of, or in combination with, stepped transitions betweendifferent pump operation speeds. For example, smooth transitions areillustrated in the pump speed pattern 1000 of FIG. 10. The pump speedpattern 1000 includes a first portion 1010 and a second portion 1020.The first portion 1010 includes a first segment 1010 a during which thespeed of the pump 16 is decreased gradually, at a strategically-selectedrate, from the first rotation speed ω1 to the second rotation speed ω2from the time T0 to the time T1. The selected rate of pump speeddecrease can be, for example, a particular linear rate or a particularnon-linear rate. During the second segment 1010 b of the first portion1010, from the time T1 to the time T2, the blood pump 16 is operated atthe second rotation speed ω2. Similarly, the second portion 1020includes a first segment 1020 a during which the speed of the blood pump16 is increased gradually, at a strategically-selected rate, from thethird rotation speed ω3 to the fourth rotation speed ω4 from the time T2to the time T3. During the second segment 1020 b of the second portion1020, from the time T3 to the time T4, the blood pump 16 is operated atthe fourth rotation speed ω4. If desired, at time T4, there is a stepincrease in the rotation speed of the rotor can be rapidly increased tothe first rotation speed ω1, and the pump speed pattern 1000 isrepeated.

The concept of creating multiple speed changes at astrategically-selected rate is based upon producing the physiologicresponse that is similar to that produced during human cardiac systoleand diastole. For example, if very accurate matching of energydissipation during a human pulse is necessary, the additional complexityof pattern 1000 may be warranted.

The pump speed pattern 1000 illustrates the difference between steppedtransitions discussed above with respect to pump speed patterns 700-900,produced by rapidly changing the rotation speed of the rotor, and thegradual transitions of the first segment 1010 a of the first portion1010 and the first segment 1020 a of the second portion 1020 of the pumpspeed pattern 1000. Such gradual transitions can be included, forexample, to mimic pressure changes exhibited during native diastole, asmay be achieved by the gradual transition of the first segment 1010 a ofthe first portion 1010 of the pump speed pattern 1000. In someimplementations, one or more of the rotation speed decreases of a pumpspeed pattern can be gradual transitions. For example, a pump speedpattern can include a gradual decrease in rotation speed from the firstrotation speed ω1 to the third rotation speed ω3 and a steppedtransition from the third pump speed ω3 back to the first rotation speedω1. Various combinations of stepped and gradual transitions can beincluded in a pump speed pattern to produce a desired arterial pressurewave form, or other desired physiologic effect. Additionally, the typeof transition between rotation speeds can affect power consumption ofthe blood pump 16, and the pump speed pattern can be selected based, atleast in part, on power consumption considerations.

For all the pump speed patterns discussed it should be appreciated thatalthough rotor speed is the technological parameter utilized to impartan artificial pulse, any physiologic effect is related to theconsequential pressure and flow patterns, including pulse pressure, themaximum time variation in rate of blood pressure change (dp/dt), and thelike. Rotor speed is not intrinsically physiologically meaningful. Thehuman vascular system naturally dampens the native pulse produced by theheart, and it will do the same for an artificial pulse produced asdescribed. The invention describes a utilitarian combination of factorsthat result in a physiological meaningful pulse. Thus, the pump speedpatterns 700-1000 described above are exemplary combinations ofparameters that result in a physiologically meaningful pulse.

The controller 20 can generate an artificial pulse with one of the pumps16, 18 while the pump 16, 18 is controlled based on pulsatility indexcalculations. The controller 20 can thus implement pulsatility indexcontrol and artificial pulse control concurrently for a single pump 16,18. As described above, pulsatility index calculations for one of theventricles 12, 14 can be used to dynamically set a speed for one or bothof the pumps 16, 18. The pump speed can be adjusted in response tochanging physiologic conditions that are reflected in the pulsatilityindex. An artificial pulse according to one of the waveforms 700-1000can be generated while pump speed is regulated based on pulsatilityindex measurements.

Referring to FIG. 11, the pump speed pattern 700 is produced by the leftblood pump 16 while the blood pump 16 is controlled at least in partbased on the left pulsatility index, PIL. To combine pulsatility indexcontrol and artificial pulse generation, the controller 20 determines aspeed for the pump 16 using the pulsatility index, PIL, as describedabove. The controller 20 sets the determined speed as the rotation speedω2. As the pulsatility index changes in response to changing physiologicconditions, the controller 20 adjusts the rotation speed ω2 in the samemanner that the controller 20 adjusts the pump speed during a continuousflow control mode.

In some implementations, the controller 20 sets the speeds ω1 and ω3 andthe durations of the period 710 a and the portion 720 to maintain avolume flow rate for the pump speed pattern 700 that is substantiallyequal to the volume flow rate produced during operation of the pump 16at the rotation speed ω2. As the controller 20 adjusts the rotationspeed ω2 based on changes in the pulsatility index, the controller 20also adjusts the speeds ω1 and ω3 to maintain an appropriate averageflow rate. As a result, the average volume flow rate produced during thepump speed pattern 700 corresponds to the average volume flow rate thatwould be produced using continuous flow control at the rotation speedω2.

Because changes in blood flow caused by the pump speed pattern 700 caninterfere with the accuracy of pulsatility index calculations, thecontroller 20 calculates the pulsatility index using blood flow ratesmeasured during selected portions of the pump speed pattern 700. Forexample, the controller 20 calculates the pulsatility index using bloodflow measured during a period in which the pump 16 is operated at aconstant speed. As a result, the effects of the artificially generatedpulse are excluded from the pulsatility index calculations.

For the pulsatility index calculations, the controller 20 usesmeasurements of the blood flow that occurs during a period 1120. Theperiod 1120 occurs during the period 710 a, during which the pump 16 isoperated at the speed ω2. In particular, the period 1120 begins at atime after the time T1, and the period 1120 can extend to the time T2,just before the pump speed is changed. The beginning of the period 1120occurs at a delay D after time T1, permitting the flow rate through thepump to stabilize after the speed change at time T1. The delay D canhave a duration of, for example, 0.05 seconds or 0.1 seconds.

To calculate the pulsatility index, the controller 20 excludesmeasurements of blood flow through the pump 16 outside the period 1120.For example, the controller 20 can ignore or not measure blood flowrates during an excluded period 1110. The excluded period 1110 includesthe period 720 a and the portion 720, during which the artificial pulsecan obscure the changes in flow rates due to the pulsatility of theventricle 12. As shown, the excluded period 1110 and the period 1120alternate such that the periods 1120 are interleaved between theexcluded periods 1110.

The controller 20 synchronizes the timing of measurements forpulsatility index calculation with the timing of the pump speed pattern700. For example, when blood flow is measured using the current draw orpower consumption of the pump 16, the controller 20 uses only current orpower measurements corresponding to pump activity during the 1120.Similarly, when blood flow is measured using inflow pressure sensors,outflow pressure sensors, or flow sensors, only sensor data receivedwithin the period 1120 is used. Thus data that is influenced byartificial blood flow variations caused by the artificial pulse areexcluded from the pulsatility index calculations.

In some implementations, the controller 10 increases the likelihood thata natural physiologic pulse coincides with the period 1120 by generatingthe artificial pulse at a non-physiologic rate. In some implementations,the artificial pulse is generated at a rate lower than 50 beats perminute, for example, at 30 beats per minute. At pulse rates belowtypical physiologic heart rates, each repetition of the pump speedpattern 700 can include an entire physiologic pulse cycle, and can alsoinclude a fraction or more of an additional cycle. Two or more completenatural pulse cycles can occur during the pump speed pattern 700.

At pulse rates below typical physiological rates, the period 710 a andthus the period 1120 comprise a larger portion of the pump speed pattern700, increasing the likelihood that each period 1120 will include atleast one complete natural pulse cycle. The duration of the period 1120can be one second or more. As an example, at an artificial pulse rate of30 beats per minute, the period 710 a can have a duration of 1.75seconds, permitting a period 1120 of 1.70 seconds. Alternatively,periods 1120 that have a duration of less than one second can also beused. Even though each period 1120 may not include a complete naturalpulse cycle, averages of pulsatility index calculations for multipleperiods 1120 or maximum or minimum rates across multiple periods 1120can be used to produce an accurate indication of pulsatility of theventricle.

In some implementations, the controller 20 synchronizes the pump speedpattern 700 with the physiologic pulse rate. Thus the controller 20 cantime the period 1120 to include at least one natural pulse cycle, toinclude multiple natural pulse cycles, or to consistently include aparticular portion of a natural pulse cycle. For example, the artificialpulse may be generated at half of the pulse rate of the natural heart,and the timing of the pump speed pattern 700 can be set such that eachperiod 1120 includes a complete natural pulse cycle. The pump speedpattern 700 can be synchronized such that successive periods 1120include every other natural pulse cycle of the patient. Othersynchronizations can also be used, for example, such that successiveperiods 1120 including every third natural pulse cycle, or such thatperiods 1120 each include two consecutive natural pulse cycles.

In use, the pump speed patterns 700-1000 can be generated by thecontroller 20, which is configured to generate an electrical drivesignal to operate the blood pump 16. For example, the controller 20 caninclude a computer system 1200, shown in FIG. 12, that outputs anelectrical current to operate the blood pump 16. In order to produce thepump speed pattern 700 described above, the controller 20 outputs afirst electrical current from the time T0 to the time T1. At the timeT1, the controller 20 reduces the output electrical current to a secondcurrent that is lower than the first electrical current, and outputs thesecond electrical current from the time T1 to the time T2. At the timeT2, the controller 20 reduces the output electrical current from thesecond current to a third current, and outputs the third electricalcurrent from the time T2 to the time T4.

The computer system 1200 includes one or more processors 1210, memorymodules 1220, storage devices 1230, and input/output devices 1240connected by a system bus 1250. The input/output devices 1240 areoperable to communicate signals to, and/or receive signals from, one ormore peripheral devices 1260. For example, a peripheral device 1260 canbe used to store computer executable instructions on the memory modules1220 and/or the storage devices 1230 that are operable, when executed bythe processors, to cause the controller 20 to generate a waveform tocontrol the operation of the pump 16 and produce a pump speed pattern,such as the pump speed patterns 700-1000.

Additionally, the controller 20 can include a sensor that provides asignal that indicates activity of the heart. For example, the controller20 can include a sensor that provides a signal indicative of powerconsumption of the blood pump 16. The signal can be used to determinewhen the left ventricle 12 contracts. For example, the power consumptionof the blood pump 16 may, for a given operating speed, increase as theleft ventricle 12 contracts. Based on the determined heart activity, thecontroller 20 can adjust the generated control waveform. For example,the controller 20 can automatically adjust the timing and duration ofthe first portion 710 and the second portion 720 of the pump speedpattern 700 such that the first portion 710 approximately coincides witha contraction of the left ventricle 12. The pump 16 is controlled suchthat the time T0 approximately coincides with a beginning of acontraction of the left ventricle 12 and the time T2 approximatelycoincides with an end of the contraction of the left ventricle 12. Thetime T4 approximately coincides with a beginning of a subsequentcontraction of the left ventricle 12. Thus, the durations of the variousportions and/or segments of the pump speed patterns described above canbe changed individually or collectively for one or more repetitions ofthe pump speed patterns. Using these techniques, the controller 20 cansynchronize the pulsatile operation of the pump with the naturalphysiologic pulse of the heart.

Alternatively, the controller 20 can generate the control waveformindependently of the activity of the heart and/or to operate inopposition to the activity of the heart, such as where the first portion710 occurs during left ventricular relaxation. Similarly, the controller20 can generate a control waveform that includes a distinctlynon-physiologic pulse rate, such as fewer than 40 high-pressure periodsper minute, and the waveform can be generated independently of nativeheart function. In some examples, the blood pump 16 can be operated toproduce distinctly physiologic pulse rates, such as between 50 and 110high-pressure periods per minute, and can be controlled dependently orindependently of heart function.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made without departingfrom the spirit and scope of the claimed invention. For example, thepump speed patterns described above can be used with various types ofblood pumps, including axial flow blood pumps and centrifugal flow bloodpumps. Similarly, the rotors of blood pumps used to produce pulsatileblood flow patterns as described above may beelectromagnetically-suspended, hydraulically-suspended,mechanically-suspended, or combinations thereof. The rotors may alsopartially be passively magnetically-suspended. However, the effect of anartificial pulse may most accurately be simulated by a pump in which therotor is electromagnetically suspended, with or without partial passivemagnetic suspension, because in general, other things being equal,electromagnetic suspension yields a high degree of responsiveness of therotor to speed change inputs. For example, mechanical bearingsassociated with mechanical suspension and/or very narrow rotor clearancegaps associated with hydraulic suspension hinder rapid acceleration ofthe rotor compared to similar pumps that employ electromagneticsuspension. Additionally, while the pump speed patterns described abovehave been described with regard to a measure of angular velocity, thepump speed patterns can be produced with regard to one or more differentmeasures of pump speeds. Additionally, there may be a delay between achange in drive signal generated by the controller 20 and a change inoperating speed of the blood pump. Thus, the controller 20 can beoperated such that changes in the output drive signal are effected at atime to produce a corresponding change in pump operating speed at adesired time, such as a time that approximately coincides with selectedactivity of the heart.

In some implementations, the pump speed patterns 700-1000 can includeadditional portions or segments during which the blood pump is operatedat other speeds. For example, at desired times, the blood pump can beoperated to produce a pump speed pattern that produces a desiredphysiologic effect, such as opening or closing the aortic valve. Suchoperation of the blood pump can interrupt a generally continuousrepetition of a selected one or more of the pump speed patternsdescribed above, or others, including an indefinite period of constantspeed, and a selected pump speed pattern can be resumed after thedesired physiologic effect has been produced. The pump speed patterns700-1000 can also include different portions or segments. For example,the second segment 710 b of the first portion 710 of the pump speedpattern 700 can include multiple pump speeds. Similarly, the transitionsbetween pump speeds, such as the reduction in pump speed from the firstrotation speed ω1 to the second rotation speed ω2, can include constant,variable, exponential, combinations thereof, or other rate of speedchange over time such that the transition, such as the first segment1010 a of the first portion 1010 of the pump speed pattern 1000, islinear, curvilinear, parabolic, logarithmic, sinusoidal, stepped, orcombinations thereof.

In some implementations, one or more of the pump speed changes in thepump speed patterns 700-1000 can be monotonic. A transition from onespeed to another may occur gradually over a period of time, yet changedirectly from one speed to another. For example, to decrease a pumpspeed from a first rotational speed to a second rotational speed, thecontroller 20 can reduce the pump speed without causing an interveningperiod of increasing pump speed. Similarly, the transition from thefirst rotational speed to the second rotational speed can occur withoutoperating the pump above the first rotational speed during thetransition.

Additionally, a blood pump can be operated according to a pump speedpattern that is selected according to a pump power consumption rateassociated with the pump speed pattern, a pump efficiency associatedwith the pump speed pattern, a blood flow rate associated with the pumpspeed pattern, and/or a rate of blood pressure change associated withthe pump speed pattern. For example, in a first mode, the controller 20can be operated to produce a pump speed pattern that produces a desiredrate of blood pressure change. When a low power condition is detected,the controller 20 can be switched to a power-saving mode to produce apump speed pattern that has a low power consumption rate, even if thedesired rate of pressure change is not produced in the power-savingmode.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made without departingfrom the spirit and scope of the claimed invention. For example, thepump speed patterns described above can be used with various types ofblood pumps, including axial flow blood pumps and centrifugal flow bloodpumps. Similarly, the rotors of blood pumps used to produce pulsatileblood flow patterns as described above may beelectromagnetically-suspended, hydraulically-suspended,mechanically-suspended, or combinations thereof. The rotors may alsopartially be passively magnetically-suspended. However, the effect of anartificial pulse may most accurately be simulated by a pump in which therotor is electromagnetically suspended, with or without partial passivemagnetic suspension, because in general, other things being equal,electromagnetic suspension yields a high degree of responsiveness of therotor to speed change inputs. For example, mechanical bearingsassociated with mechanical suspension and/or very narrow rotor clearancegaps associated with hydraulic suspension hinder rapid acceleration ofthe rotor compared to similar pumps that employ electromagneticsuspension. Additionally, while the pump speed patterns described abovehave been described with regard to a measure of angular velocity, thepump speed patterns can be produced with regard to one or more differentmeasures of pump speeds. Additionally, there may be a delay between achange in drive signal generated by the controller 20 and a change inoperating speed of the blood pump. Thus, the controller 20 can beoperated such that changes in the output drive signal are effected at atime to produce a corresponding change in pump operating speed at adesired time, such as a time that approximately coincides with selectedactivity of the heart.

In some implementations, the pump speed patterns 700 to 1000 can includeadditional portions or segments during which the blood pump is operatedat other speeds. For example, at desired times, the blood pump can beoperated to produce a pump speed pattern that produces a desiredphysiologic effect, such as opening or closing the aortic valve. Suchoperation of the blood pump can interrupt a generally continuousrepetition of a selected one or more of the pump speed patternsdescribed above, or others, including an indefinite period of constantspeed, and a selected pump speed pattern can be resumed after thedesired physiologic effect has been produced. The pump speed patterns700 to 1000 can also include different portions or segments. Forexample, the second segment 710 b of the first portion 710 of the pumpspeed pattern 700 can include multiple pump speeds. Similarly, thetransitions between pump speeds, such as the reduction in pump speedfrom the first rotation speed ω1 to the second rotation speed ω2, caninclude constant, variable, exponential, combinations thereof, or otherrate of speed change over time such that the transition, such as thefirst segment 1010 a of the first portion 1010 of the pump speed pattern1000, is linear, curvilinear, parabolic, logarithmic, sinusoidal,stepped, or combinations thereof.

In some implementations, the pump speed changes in the pump speedpattern 700 can be monotonic. A transition from one speed to another mayoccur gradually over a period of time, yet change directly from onespeed to another. For example, to decrease a pump speed from a firstrotational speed to a second rotational speed, the controller 20 canreduce the pump speed without causing an intervening period ofincreasing pump speed. Similarly, the transition from the firstrotational speed to the second rotational speed can occur withoutoperating the pump above the first rotational speed during thetransition.

Additionally, a blood pump can be operated according to a pump speedpattern that is selected according to a pump power consumption rateassociated with the pump speed pattern, a pump efficiency associatedwith the pump speed pattern, a blood flow rate associated with the pumpspeed pattern, and/or a rate of blood pressure change associated withthe pump speed pattern. For example, in a first mode, the controller 20can be operated to produce a pump speed pattern that produces a desiredrate of blood pressure change. When a low power condition is detected,the controller 20 can be switched to a power-saving mode to produce apump speed pattern that has a low power consumption rate, even if thedesired rate of pressure change is not produced in the power-savingmode.

As mentioned above, in some implementations, the blood pumps 16, 18 canbe used to assist a patient's heart during a transition period, such asduring a recovery from illness and/or surgery or other treatment. Inother implementations, the blood pumps 16, 18 can be used to partiallyor completely replace the function of the patient's heart on a generallypermanent basis.

The subject matter and the functional operations described in thisspecification can be implemented in digital electronic circuitry, intangibly-embodied computer software or firmware, in computer hardware,including the structures disclosed in this specification and theirstructural equivalents, or in combinations of one or more of them. Thesubject matter described in this specification can be implemented as oneor more computer programs, i.e., one or more modules of computer programinstructions encoded on a tangible non transitory program carrier forexecution by, or to control the operation of, data processing apparatus.The program carrier can be a computer storage medium, for example, amachine-readable storage device, a machine-readable storage substrate, arandom or serial access memory device, or a combination of one or moreof them, as described further below. Alternatively or in addition, theprogram instructions can be encoded on an artificially generatedpropagated signal, e.g., a machine-generated electrical, optical, orelectromagnetic signal, that is generated to encode information fortransmission to suitable receiver apparatus for execution by a dataprocessing apparatus.

The term “data processing apparatus” encompasses all kinds of apparatus,devices, and machines for processing data, including by way of example aprogrammable processor, a computer, or multiple processors or computers.The apparatus can include special purpose logic circuitry, e.g., an FPGA(field programmable gate array) or an ASIC (application specificintegrated circuit). The apparatus can also include, in addition tohardware, code that creates an execution environment for the computerprogram in question, e.g., code that constitutes processor firmware, aprotocol stack, a database management system, an operating system, or acombination of one or more of them.

A computer program (which may also be referred to or described as aprogram, software, a software application, a module, a software module,a script, or code) can be written in any form of programming language,including compiled or interpreted languages, or declarative orprocedural languages, and it can be deployed in any form, including as astand-alone program or as a module, component, subroutine, or other unitsuitable for use in a computing environment. A computer program may, butneed not, correspond to a file in a file system. A program can be storedin a portion of a file that holds other programs or data, e.g., one ormore scripts stored in a markup language document, in a single filededicated to the program in question, or in multiple coordinated files,e.g., files that store one or more modules, sub programs, or portions ofcode. A computer program can be deployed to be executed on one computeror on multiple computers that are located at one site or distributedacross multiple sites and interconnected by a communication network.

The processes and logic flows described in this specification can beperformed by one or more programmable computers executing one or morecomputer programs to perform functions by operating on input data andgenerating output. The processes and logic flows can also be performedby, and apparatus can also be implemented as, special purpose logiccircuitry, e.g., an FPGA (field programmable gate array) or an ASIC(application specific integrated circuit).

Computers suitable for the execution of a computer program can include,by way of example, general or special purpose microprocessors or both,or any other kind of central processing unit. Generally, a centralprocessing unit will receive instructions and data from a read onlymemory or a random access memory or both. The essential elements of acomputer are a processing unit for performing or executing instructionsand one or more memory devices for storing instructions and data. Acomputer can also include, or be operatively coupled to receive datafrom or transfer data to, or both, one or more mass storage devices forstoring data, e.g., magnetic, magneto optical disks, or optical disks.However, a computer need not have such devices. Moreover, a computer canbe embedded in another device, e.g., a pump, a pump controller, or aportable storage device, e.g., a universal serial bus (USB) flash driveor other removable storage module, to name a few.

Computer readable media suitable for storing computer programinstructions and data include all forms of non-volatile memory, mediaand memory devices, including by way of example semiconductor memorydevices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks,e.g., internal hard disks or removable disks; magneto optical disks; andCD ROM and DVD-ROM disks. The processor and the memory can besupplemented by, or incorporated in, special purpose logic circuitry.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made without departingfrom the spirit and scope of the disclosure.

What is claimed is:
 1. A controller for a heart assist system,comprising: a processing unit configured to generate a pulsatility indexfor a right blood pump, set a speed of the right blood pump based on thepulsatility index for the right blood pump, generate a pulsatility indexfor a left blood pump, and set a speed of the left blood pump based onthe pulsatility index for the left blood pump.
 2. A method ofcontrolling a heart assist system, comprising: calculating a pulsatilityindex for a right blood pump, the right blood pump supporting a rightventricle; controlling the speed of the right blood pump based on thepulsatility index for the right blood pump; calculating a pulsatilityindex for a left blood pump, the left blood pump supporting a leftventricle; and controlling the speed of the left blood pump based on thepulsatility index for the left blood pump.
 3. The method of claim 2,wherein the right blood pump is a rotary pump, and wherein the leftblood pump is a rotary pump.
 4. The method of claim 2, wherein thepulsatility index for the right blood pump indicates a load on the rightventricle experienced during contraction of the right ventricle, andwherein the pulsatility index for the left blood pump indicates a loadon the left ventricle experienced during contraction of the leftventricle.
 5. The method of claim 2, wherein each pulsatility index (PI)is calculated over a control interval according to the followingequation: PI=(Q_(max)−Q_(min))/Q_(ave), where Q_(max) is a maximum flowrate through the pump in the control interval, Q_(min) is a minimum flowrate through the pump in the control interval, and Q_(ave) is an averageflow rate through the pump over the control interval.
 6. The method ofclaim 2, further comprising: measuring blood flow through the rightblood pump; measuring blood flow through the left blood pump; andcontrolling a speed of one of the rotary blood pumps based on themeasured blood flow through the other blood pump.
 7. The method of claim6, further comprising determining whether the blood flow through one ofthe blood pumps exceeds a flow threshold, wherein controlling the speedof the right blood pump and controlling the speed of the left blood pumpcomprise, when the pulsatility index for the right blood pump is below afirst target level and the pulsatility index for the left blood pump isbelow a second target level: when the blood flow through the one of theblood pumps does not exceed the flow threshold, decreasing the speed ofthe right blood pump and decreasing the speed of the left blood pump,and when the blood flow through the one of the blood pumps exceeds theflow threshold, maintaining the speed of the right blood pump andmaintaining the speed of the left blood pump.
 8. The method of claim 7,wherein controlling the speed of one of the rotary blood pumps based onthe measured blood flow through the other blood pump comprises:determining that a relationship between the measured blood flow throughthe right blood pump and the measured blood flow through the left bloodpump is not satisfied; and in response to determining that therelationship is not satisfied, adjusting the speed of the one of theblood pumps such that the relationship is achieved.
 9. The method ofclaim 2, wherein controlling the speed of the right blood pump isfurther based on the pulsatility index for the left blood pump.
 10. Themethod of claim 2, wherein controlling the speed of the left blood pumpis further based on the pulsatility index for the right blood pump. 11.The method of claim 2, further comprising detecting a heart rate,wherein controlling the speed of the right blood pump is further basedon the heart rate, and wherein controlling the speed of the left bloodpump is further based on the heart rate.
 12. The method of claim 11,further comprising determining whether the heart rate exceeds athreshold heart rate, wherein controlling the speed of the right bloodpump and controlling the speed of the left blood pump comprise, when thepulsatility index for the right blood pump is below a first target leveland the pulsatility index for the left blood pump is below a secondtarget level: when the heart rate does not exceed the threshold heartrate, decreasing the speed of the right blood pump and decreasing thespeed of the left blood pump, and when the heart rate exceeds thethreshold heart rate, maintaining the speed of the right blood pump andmaintaining the speed of the left blood pump.
 13. The method of claim 2,further comprising operating the left blood pump to produce anartificially induced pulsatile blood flow; and calculating the leftpulsatility index such that data influenced by artificial blood flowvariations of the artificially induced pulsatile blood flow are excludedfrom calculating the left pulsatility index.